On July 8, 2026, the European Commission notified the World Trade Organization of a draft Commission Regulation amending Regulation (EC) No 1223/2009 on cosmetic products, known in the sector as Omnibus Act IX. The draft would add 16 substances to Annex II (prohibited), revise Annex III and Annex V entries for CBD, BHA, Hydroxyapatite (nano), Butylparaben and mercury preservatives, and align the Cosmetics Regulation with CMR classifications under Commission Delegated Regulation (EU) 2025/1222. The CMR-driven Annex II bans and related Annex V changes would apply from February 1, 2027.
This is still a notified draft, not an adopted act. Formulation, Responsible Person and supply-chain teams placing cosmetics on the EU market should treat the WTO draft text and its draft annex as the operative compliance blueprint while the file advances through adoption.
What exactly changes in Annexes II, III and V?
Omnibus Act IX has two tracks. First, it incorporates substances newly classified as CMR under Delegated Regulation (EU) 2025/1222 (the 23rd ATP to the CLP Regulation) into Annex II of Regulation (EC) No 1223/2009, because no Article 15 exemption request was filed for those substances. Second, it implements recent Scientific Committee on Consumer Safety (SCCS) opinions on ingredients already in commercial use.
The draft adds 16 Annex II prohibitions, including ozone, dinitrogen oxide, Benzophenone-1, Benzophenone-2, Basic Brown 16, Basic Blue 99, tetrahydrofurfuryl methacrylate, trimethyl phosphate, α-methylstyrene, several fluorinated monomers, and prostaglandins and their analogues used in eyelash-growth cosmetics. Separately, Annex III would authorise Cannabidiol (CBD) at a maximum of 0.19% in leave-on, rinse-off and oral care products, with Δ9-THC impurity capped at 0.00025% (2.5 ppm), and would restrict Butylated Hydroxyanisole (BHA) to 0.07% in leave-on and rinse-off products, excluding oral care and inhalation-exposure products. Hydroxyapatite (nano) limits in toothpastes and mouthwashes would rise under a revised Annex III entry 372, while remaining banned in other product types.
On preservatives, Annex V entries 16 and 17 (Thiomersal and phenylmercuric salts) would be deleted, and Annex II entry 221 on mercury would lose its remaining Annex V carve-outs. Butylparaben would move from shared entry 12a into a new entry 12b with child-specific concentration limits; Propylparaben would stay in entry 12a unchanged.
Who is in scope, and which deadline is binding first?
Every manufacturer, importer and Responsible Person placing cosmetic products on the Union market is in scope, including non-EU brands that sell into the EU. The binding date for the CMR block (the first 11 new Annex II entries tied to Delegated Regulation (EU) 2025/1222, plus Annex V entry 12b) is February 1, 2027, matching the CLP application date of those classifications.
| Change set | Annex impact | Proposed timing |
|---|---|---|
| CMR substances from Delegated Regulation (EU) 2025/1222 | 11 new Annex II entries; Annex V entry 12b (Butylparaben) | February 1, 2027 |
| SCCS-driven bans (Benzophenone-1/2, hair dyes, prostaglandins, mercury) | Further Annex II additions; Annex V entries 16 and 17 deleted | Place on market: 12 months after entry into force; make available: 24 months after entry into force |
| CBD, BHA, Hydroxyapatite (nano) | New or revised Annex III restrictions | Same 12 / 24 month transitional ladder after entry into force |
Until the regulation is adopted and published, the entry-into-force clock for the SCCS track has not started. Teams should still lock reformulation plans to the fixed February 1, 2027 CMR date now, because that date does not wait on WTO comments.
What should compliance teams do before February 1, 2027?
Map every SKU against the 16 proposed Annex II substances and the CBD, BHA, Hydroxyapatite (nano), Butylparaben and mercury rules. Prioritise eyelash serums with prostaglandin analogues, UV/light-stabiliser systems using Benzophenone-1 or Benzophenone-2, antioxidant systems with BHA above 0.07%, CBD formulas above 0.19% or with THC above 2.5 ppm, and any remaining Thiomersal or phenylmercuric preservatives.
Update CPNP notifications, Product Information Files and claims after each reformulation. Brief suppliers on impurity specs for CBD (THC) and on particle-size specifications for Hydroxyapatite (nano). Continuous, per-jurisdiction monitoring of Cosmetics Regulation annex amendments surfaces Omnibus drafts at the WTO and Official Journal stages the moment they publish, so Responsible Persons are not waiting on trade press alone.
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Confirm whether each formula uses any of the 16 Annex II candidates, set the February 1, 2027 cutover for CMR-linked SKUs, and schedule the 12 / 24 month place-on-market / make-available ladder for the SCCS track once the act is published. Brief regulatory affairs, R&D and procurement together, then keep watching the file through Obsidian as the draft moves from WTO notification to adoption.
